WO2008009469A1

WO2008009469A1 - Multi-lancet device

Info

Publication number: WO2008009469A1
Application number: PCT/EP2007/006482
Authority: WO
Inventors: Joachim Hoenes; Hans-Peter Haar; Herbert Harttig; Hans-Juergen Kuhr; Ortrud Quarder; Dirk Voelkel; Volker Zimmer
Original assignee: Roche Diagnostics Gmbh; F. Hoffmann-La Roche Ag
Priority date: 2006-07-21
Filing date: 2007-07-20
Publication date: 2008-01-24
Also published as: US20090177118A1; CA2657453A1; US8394035B2; JP2009544342A; CN101489484B; ATE491391T1; EP1880670B1; HK1135867A1; EP1880670A1; DE502006008513D1; CN101489484A

Abstract

The invention relates to a device for collecting samples of body fluids, comprising at least one lancet, which has a lancet body with at least two tips of different length. The device is characterized in that it has a selection means, with the aid of which only one tip is selected prior to the puncture procedure. This selection means can have different functions and shapes. The selection means is used to select one tip from a plurality of lancet tips of different lengths and to make only this tip available for use in the puncturing procedure. Since the various tips are mounted on a lancet body, it is possible to employ a buckling element, for example, to make only one lancet tip available for use, which buckling element buckles one of the various tips out from the plane of the lancet body. This is especially preferable in lancet tips that are arranged linearly in relation to one another.

Description

Multi lancets

Technical area

The invention is in the field of lancing devices for the diagnostic determination of blood parameters.

State of the art

The collection and analysis of body fluids takes place in many areas of medical diagnostics. Therefore, it is also desirable to enable routine tests outside the laboratory quickly and reproducibly. The testing can be carried out with various body fluids, such. B. blood and / or interstitial fluid. These fluids can be examined for different characteristics. The results of this study are important in order to make reliable diagnoses, therapeutic measures and therapy follow-up.

The analysis of body fluids begins with the recovery of the fluid. One method of obtaining body fluid is to create a minimal wound in the patient's skin using a needle, lancet, or knife. The body fluid obtained can either be collected in small vessels or directly in contact with a test element such. B. a test strip for analysis. Most of these lancing devices require a manual insertion of the lancet in the lancing device. This is a very cumbersome handling with a very frequent use of the lancing device. A magazining of lancets can solve this problem, with many safety issues to consider. It should be noted, for example, that the safety of the patient is ensured when using the lancing device. In addition, the system should not be too complex, otherwise it would not be well handled by the patient. Another important feature in addition to the magazine, is the ability to adjust the piercing depth before the lancing process. This can be ensured on the device side, as for example in the patent application

WO 2006038044 is described. Due to the device-side setting of the piercing depth, a very complicated mechanism is necessary since the drive of the lancet and the piercing depth control mechanism must be adjusted to each other. Alternatively, the puncture depth could also be controlled by the lancets.

Although in the prior art lancing devices are described which have more than one lancet, there is no possibility for the user to influence the lancing depth before the puncture. For example, US Pat. No. 4,794,926 describes a lancet system in which a plurality of lancets, which can be used individually for the lancing process, are stored on a base body. However, this system also does not provide a means for selecting the puncture depth for the patient prior to the lancing process.

From the disadvantages of the prior art, the object arises of generating a lancing device that is easy to handle and is inexpensive to manufacture and allows easy adjustment of the lancing depth.

This object is solved by the subject matter of the invention as characterized in the independent patent claims. Preferred embodiments are subject of the dependent claims.

The invention relates to a device for obtaining body fluids, which has at least one lancet, comprising a lancet body having at least two tips of different lengths. The device is characterized in that it has a means for selection, by means of which only one tip is selected before the puncture. This selection means may have various functions and shapes. The means for selection serves to select a tip from a plurality of lancet tips having different lengths and to provide only that selected tip for use in the lancing process. Since the lancet tips have different lengths, the lancing depth can be adjusted by the choice of the lancet tip to be used for the lancing process. During the lancing process itself, the selected lancet tip and the other lancet tips are arranged so that only the selected lancet tip penetrates into the body to be stung.

This device for obtaining body fluid has the advantage that the device itself no further control of the puncture depth must be made, as in the prior art (eg WO 20060380449) is the case. This requires no special Tuning of the drive with the device-side puncture depth control. On the device itself no adjustable parts need to be attached and adjusted. As a result, inexpensive drives and housings can be used.

In the device described here, the selection of the piercing depth therefore takes place via the selection of the lancet tip. This means that several lancet tips with different lengths must be provided. These different lengths lancet tips are arranged on a lancet body. The type of arrangement can include all possible shapes and geometries. Thus, the lancet tips can be arranged linearly, wherein the tips can point in the same or in opposite directions. However, the lancet tips can also not point linearly in different directions, for example by being arranged at different angles on the lancet body. A preferred embodiment with different lancet tips, which are arranged in different directions on the lancet body, is a star-shaped arrangement of the tips. In a particularly preferred embodiment, the lancet tips are mounted in a plane on the lancet body.

After selecting a particular lancet tip, the single tip may be used by moving the lancet body so that only one lancet tip faces the direction of the piercing body as the lancet body moves. The other lancet tips point in other directions and consequently are not pierced into the body during the insertion process. This arrangement of selected and unselected tips can be realized by different geometries of the lancet body in different ways. For this purpose, various means for selection are necessary.

Various means for selecting the tip to be used may be provided for the various arrangements of the lancet tips. This selection means may include, for example, a label on the lancet itself or on the lancet body. Such a marking can be recognized, for example, optically, mechanically or electrochemically in the device. For this purpose, a sensor can be used which makes it possible to perform an optical, mechanical or electrochemical registration of the arrangement of the lancet body in the device. This marking may, for example, be a notch or else a coloring of a part of the lancets or of a possible carrier if the lancet is applied to a carrier. Furthermore, the means for selection may be a device that allows the lancet body to be positioned so that the selected lancet tip is provided for use so that it can interact with a drive unit to be moved to the puncture. This may be, for example, the same device that is also used for further indexing the lancet body. Each time the patient latches, the lancet body is moved further by a lancet tip. This can be displayed to the user via a counter, so that it is always apparent to the user which lancet length is currently provided for the puncture. It should be prevented that the device can be clocked back so that no repeated use of a lancet tip is possible. However, any other type of selection is also possible, which makes it possible to ensure a positioning of the lancet body in order to select a single lancet tip for use and to position the puncture so to the drive unit, without that more than one lancet tip is used. Even with the star-shaped arrangement of the lancet tips on the lancet body and the arrangement of different tips at different angles on the lancet body, a marking of optical or mechanical nature can be made as described above. Further possibilities for marking the lancet body are a different magnetization or different impedance of different regions of the lancet body or of the lancet tips. In the optical detection of the lancet body or the individual

Lancet tips, the device requires an optical detection means such as an optical sensor. By contrast, in the case of mechanical recognition of the positioning of the lancet body, for example, a latching mechanism is required, which enables notches in the lancet body to lead to an exact positioning of the lancet body and thus of the lancet tips. Regardless of the manner of selection, the lancet tip selected by the user, it is important to achieve accurate positioning of the lancet body by selection. By selecting and then accurately positioning the lancet body, it is ensured that the drive unit moves the lancet body in such a way that only the selected lancet tip penetrates into the body.

When speaking of positioning in this context, the positioning of the selected and selected lancet tip or lancet body with respect to the Drive unit on the one hand and the puncture meant. It should thus be ensured that the selected lancet tip can be moved by the drive unit so that a puncture can be made on the part of the body provided for the puncture.

As an alternative to a marking of a part of the lancet or the carrier of the lancet, the carrier or the lancet can be positioned so precisely in the device that only by rotation and / or displacement of the lancet body or the carrier, the selected lancet tip can be provided for use ,

Since the different tips are attached to a lancet body, can for the

Provision of only one lancet tip for use, for example, a buckling element can be used, which kinks one of the various tips of the lancet body plane. This is particularly preferred in the case of lancet tips that are arranged linearly relative to one another. Here, the buckling element forms the means for selection. The kinking makes it possible, upon movement of the lancet body to the puncture, to move only the kinked lancet in the direction of the body part to be staked. The kinking is thus prevented that more than one lancet tip penetrates into the body.

An alternative to kinking the selected lancet tip is the sufficient spacing of the lancet tips to each other so that a tip can be positioned and used without further tips penetrating the body, although all the tips are particularly also disposed in the same direction on a lancet body. Even with simultaneous movement of all lancet tips during the insertion process can be ensured by the spacing that only a lancet tip penetrates into the body. Here, therefore, the means for selection due to a sufficient spacing of the

Lancet tips realized. Advantageously, the lancet body thus has a plurality of coupling elements, which enable a coupling of the lancet to the drive unit at different locations of the lancet body. Depending on the selected coupling element is carried out according to a selection of the lancet tip, which is to be used for a lancing process. In the described embodiment, therefore, the coupling elements are part of the means for selection. If the lancet tip is to be bent away from the lancet body, then the lancet should have special material properties. For example, the lancet can be a flat lancet and / or have a kink area. In a preferred embodiment, the lancet is a flat lancet and has a kink area. In a particularly preferred embodiment, the lancet body is also designed flat. The kink region of the lancet, which may also be outside the tip region, has at least one structure with modified rigidity. This at least one structure with modified rigidity is referred to below as embossing. The embossing can be achieved by z. As etching, punching or hammering or other metal-working measures are worked in or on the lancet. The stiffness can therefore preferably by the variation of the

Geometry of the lancet or by varying the amount of material used to produce the lancet. A preferred embodiment includes more than one embossment in the kink region of the lancet. A particularly preferred embodiment of this embossment is a triple embossing in the bending region of the lancet, which extends over at least part of the longitudinal extent of the lancet. An embossing extends from the distal

End of the lancet in the axial direction towards the proximal end of the lancet. The length of the embossing is variable. This embossing can be introduced from two sides in the flat lancet. This different direction of embossing causes the lancet tip to bend in the opposite direction to the lancet body. As a result, the bent surfaces are lifted at an angle of preferably up to 100 ° from the lancet body plane. As a result, the lancet tip is moved out of the plane of the lancet body.

The transmission of the force to the lancet can take place by a buckling element, for example a plunger, which is pressed onto the lancet. In a special embodiment with more than one embossing, it is possible to transfer the force to the lancet by, for example, guiding the lancet body with the lancet tip over the plunger or pushing the plunger against the lancet tip. In this case, a sufficiently large force (threshold force) acts on the lancet in order to move the lancet tip out of the lancet body plane. If the lancet body is a carrier tape or if the lancet body is fixed on a carrier tape, then it may be necessary to bend the lancet tip back into the carrier tape plane after the puncture in order to enable Remagazinierung. For this purpose, a return element can serve, which after the puncture the lancet tip again leads over to its original position before kinking, as shown in Figures 8 ad is. Furthermore, the Remagazinierung done due to the material properties of the lancet. Thus, the lancet may be made of a shape memory material, such as Nitinol, which flexes in the cool state (such as room temperature) and the curved shape is maintained until heated. This rebreathing temperature is between 34-60 ⁰ C depending on the alloy.

A preferred embodiment for the arrangement of different lengths of lancet tips is a lancet wheel. In this case, circular lancets are arranged in a plane having different long lancet tips, or whose lancet tips are bent at different locations in order to vary the length of the lancet tip. In this case, the lancet tip can also be designed in the form of a cutting edge.

The material of the lancet is preferably metal, more preferably steel. The lancet can also consist of other materials and material combinations. In addition, the material should be of the shape that it can be worked at the distal end of the lancet tip to a sharp point, otherwise the stitch is too much pain generated. The manufacture of lancets in general is well known in the art, such as in DE 19604156 or EP 0565970. If the lancet is kinked prior to lancing, the lancet material should be of the shape that the lancet is kinkable upon application of force has enough rigidity to use in the

Penetrate skin without altering its shape. In a preferred embodiment, the lancet body is worked together with the lancet tips in one piece. This can be produced, for example, by etching or punching the steel lancet.

Various methods can be used to actuate the lancet. The choice of method depends primarily on the geometry of the device. Thus, the device can only drive a lancet, or the device can be combined in a system with other elements, such as test elements, detectors, evaluation units and display units. In a preferred embodiment, a plurality of lancet bodies having a plurality of test elements are arranged on or on a carrier tape. The carrier tape can here as

Lancet body act. For example, the lancet may be fixed to the carrier tape at its proximal end such that a portion of the lancet may be moved in relation to or with the carrier tape while the proximal end is in contact with the carrier at least at one point Carrier tape is connected. Another preferred attachment of the lancet, the fixation of the lancet body to the carrier tape, wherein the tip portion detaches from the carrier tape. The controlled movement of the lancet can be done by moving the carrier tape or by gripping the lancet with a gripping element, wherein the lancet tip is moved out of the plane of the carrier tape with the carrier tape. This movement can be done by means of a

Drive element can be performed, which transmits power perpendicular to the carrier belt plane on the lancet. The power transmission takes place by means of a drive element, e.g. may be a plunger or a gripping member which engages and moves the lancet on its lancet body. Here, in a preferred embodiment, the penetration depth of the blood sampling device is freely selectable. To regulate the puncture depth, in addition to the length of the lancet tip, the movement of the lancet can be defined by a variable stop element against which the lancet strikes during the piercing process. Depending on the position of the stop element is in this way the length of the lancet tip, which pierces into the body and thus varies the penetration depth. The stop element can be integrated, for example, in the housing. Furthermore, the lancet itself can serve as a stop element, wherein the puncture depth is defined by the length of the protruding from the lancet body possibly bent tip. In this case, the lancet body forms a barrier for the further penetration of the lancet into the skin.

To drive the lancet, ballistic or slotted guided mechanisms known in the art, e.g. in DE 19604156, EP 0565970, US 5318584 or US 4924879. A preferred embodiment for driving the lancet is the free movement of the lancet after power transmission by the drive element, such as the plunger. In this embodiment, a pulse is transmitted from the drive element to the lancet and the lancet moves without further guidance by the drive element in the direction of the housing opening. The movement of the lancet can be performed by additional elements on the housing.

For hygienic use of the system, the lancet at least the tip area of the lancet is protected by a sterile barrier. This sterile protection may be a film which additionally contains an antibacterial agent such as silver. Preferably, the lancet over the entire lancet body is covered with this film as a sterile protection. The film may, when using a carrier tape over a portion of the carrier tape extend and be connected. This sterile protection can consist of a polymer layer which is applied after the production of the lancet. This polymer layer is destroyed or punctured by the lancet tip as it applies the threshold force to the lancet tip and exposes the lancet tip. Alternatively, the sterile guard may be removed prior to use of the lancet. Preferably, the sterile protection is hereby removed as a whole.

In a preferred embodiment, the lancet has at least in its tip region a channel which serves to collect blood from the wound with the lancet. This embodiment is referred to below as a microsampler. The blood collected in the microsampler can then be transferred to a test element and detected by a detection system (eg, optically or electrochemically) and evaluated by an evaluation system.

The invention furthermore relates to a lancet for piercing a body part.

According to the invention, the lancet body has at least two tips which have different lengths. The lancet is designed such that a tip is selectable, so that a lancing process with a defined puncture depth depending on the length of the selected tip can be done. Further, according to the present invention, the unselected tips are positionable relative to the selected tip during a piercing operation such that a piercing operation is performed exclusively with the selected tip, while the unselected tip is not involved in the piercing process. In this way, a regulation of the penetration depth by the selection / selection of a specific tip of the lancet is possible. For example, a lancet tip can be selected by kinking a tip, the lancet having a kink area for this purpose, as already described. But it is also possible to design a coupling element of a lancet in such a way that a drive unit can be coupled to different positions of the lancet or the lancet is coupled in different positions to the drive unit, thereby selecting a tip for performing a lancing operation. In general, the coupling element is to be understood as the part of the lancet which allows coupling between the lancet and the drive unit of a device. For example, a coupling element may include a recess in the lancet body into which a drive unit may engage. But there are others too Embodiments possible, such as structures of the lancet body, as they are already well known in the prior art and are described in systems that allow coupling a provided for replacement lancet to a blood collection system. In addition, a plurality of coupling elements of a lancet are conceivable, so that a selection of a tip is made by selecting a corresponding coupling element. In the described embodiments, for example, the coupling element of the lancet is at the same time a component of a means for selection, as has already been shown several times. In general, it thus appears that, depending on the respective configuration of a system / device which is suitable for use of the lancet according to the invention, various embodiments of a coupling element are conceivable which advantageously simultaneously enable selection of a lancet tip. Furthermore, the lancet according to the invention may additionally contain selection means, as already described. By way of example, markings of the respective lancet tips may be mentioned here, which permit a targeted selection of a lancet tip, for example by means of an optical detection of the marking, in a corresponding device and thus allow a selection of the penetration depth. Advantageously, therefore, in such systems, the means for selection are both part of the device and the lancet itself, with a corresponding interaction between the device and lancet allows selection of a lancet tip.

The invention also relates to a system for obtaining body fluid. As already mentioned, in the system the device can be combined with further different elements for the analysis of a body fluid (eg test element, detector, evaluation unit etc.). By way of example, a system with a carrier tape will be described, but not limited to the selection of elements in a system. This system preferably consists of a housing in which a substantially planar carrier tape is mounted, and at least two lancets, which are arranged lying on the carrier tape. The housing has at least one opening, to which the lancet is moved during the lancing process and, if necessary, can pass through it. The substantially planar carrier tape is preferably wound on two spools. But it can also be used other storage options for magazining the used and unused lancets. When using two lancet storage magazines, the unused lancets are on one spool and the used lancets are on the other spool. The lancets are made of a material that is soft enough to be wound on the carrier tape without kinking. On the other hand, the lancet material is so stable that the lancet will not be deformed upon actuation and entry into the skin. Alternatively, the lancets are arranged transversely on the carrier tape so that bending of the lancet can be avoided. Another way to avoid bending the unused lancets is to choose the diameter of the spool on which the lancets are stored, so that the lancets are hardly bent when rolled up.

The lancet has at least two lancet tips located on the lancet body. After the user has selected the puncture depth, the means of selection (in this case a buckling element) provides the lancet tip for use. In this preferred embodiment, the lancet is thus selected by kinking. By the buckling element, which acts on the lancet so, the lancet tip is variable with respect to the rest of the lancet body in their orientation. In a preferred embodiment, the force acting on the lancet prior to actuation, the buckling element may regulate the location of the force applied to the lancet body. For this purpose, the buckling element can be controlled by a control element. For power transmission can serve a ram or folding lever. Conventional lancets can be used in the system, preferably the lancets are shaped as flat lancets.

The lancet is moved by a drive element in the direction of the housing opening in order to exert the lancing process there. In the case of the bent lancet tip, this may take place after or during this bending process. In this case, at least a part of the lancet moves in the direction of the housing opening and pierces the skin of the patient. At the injection site, a drop of blood forms, which is used for analysis. If a test element is on the carrier tape, the carrier tape is transported so far if necessary, that the test element is located below the housing opening. The blood drop can be applied to the test element without the patient having to take further steps. The blood reacts with one or more reagents located on the test element, such as those shown in FIG. Example from the documents EP-A 0 885 591, EP-B 0 535 480 and EP-B 0477322 are known. The test element is analyzed by means of a detector. The blood can be assayed for various components as known in the art. For example, the analysis may be directed to blood components such as hematocrit, glucose, cholesterol, coagulation, iron and others. Different methods can be used for the analysis. Thus, for example, electrochemical detection reactions can be used, but also optical (eg reflection, absorption, fluorescence, Raman spectroscopy) or magnetic detection reactions. Typically, the liquid is contacted with a test system with reaction between a test element and the liquid. Thus, detection by means of an optical test element is based on a color reaction between the liquid and the detection reagent. Examples of these reactions are disclosed in U.S. Patents 3,802,842; 4,061,468 and 4,490,465.

When using the device, the system performs various steps. A puncture depth is selected on the device. This selection causes the system to select a lancet corresponding to the preselected lancing depth according to a selection mechanism described above using the means for selection. If the lancet is to be kinked before the puncture, it is brought into a position in which it is brought into the kinked state by the action of a threshold force on the lancet body. In this case, preferably the sterile protection is broken. If the lancet is not bent before the puncture, the sterile protection is removed before or during the puncture. The lancet will, if necessary, until the

Transported opening of the housing. There it is actuated by means of a drive element and can thereby escape to a part of the housing opening. In the Aktuationsvorgang the lancet enters at least a part of the skin of the patient and then back into the device.

If the lancet is located on a carrier tape, then this carrier tape can be transported further and wound onto the second reel. There, the lancet lies flat again on the carrier tape. This Remagazinierungsvorgang is described in the patent application US 20050245845.

In an integrated system, in which also test elements on the carrier tape, preferably applied alternately with the lancets, the test element is after the lancing process transported to the housing opening to receive the drop of blood for analysis. The test element can be transported to the detector and measured there.

figure description

Figure 1: Schematic representation of a lancet body with a plurality of lancet tips of different lengths, which are mounted on two sides of the lancet body.

Figure 2: Schematic representation of a star-shaped arrangement of the lancet tips on a lancet body.

Figure 3: Schematic representation of a kinkable tip on the lancet body.

Figure 4: Schematic representation of a microsampler with kink on a lancet body

Figure 5: Schematic representation of a microsampler with impressed kink area on a lancet body

Figure 6: Schematic representation of a system with a carrier tape, are mounted on the lancet, with selection means, lancing and optics.

Figure 7a: Schematic representation of a circular arrangement of different

Lancets that have different lengths or different bending ranges.

FIG. 7b: Schematic representation of a lancet arm with a cutting edge at the distal end of the lancet.

Figure 8 a-d: Schematic representation of a buckling before the puncture process by means of a buckling device, which also contains a return element.

Figure 9: Schematic representation of a lancet wheel, which is moved with eccentric rollers. FIG. 1 shows a lancet (1) which consists of a lancet body (2) and at least 2 lancet tips (3). In the arrangement shown in Figure 1, a portion of the lancet tips (3) on one side of the lancet body (2) shown here rectangular and the remaining part of the lancet tips (3) on the opposite side of the lancet body (2). In such a band-like structure of the lancet body (2), a plurality of 100 lancets may be arranged. Preferably, up to 100 lancet tips (3) are arranged on the lancet body, which can then be wound on a belt, for example. In a further embodiment, up to six lancet tips (3) are arranged on the lancet body (2), wherein the lancet bodies can then be arranged in a stackable manner in a magazine. When using a carrier tape for magazining the lancet tips, it is also possible that the carrier tape serves as a lancet body on which the lancet tips are arranged. This carrier tape may for example consist of fabric, or else be a metal band. The means for selection, ie the selection of the length of the lancet and thus the puncture depth, can in this case be a device element which is used for

Further clocking the device is used. A precisely adjusted mechanism advances the tape from one lance tip to the next during each cycle. For this purpose, the lancet tips must be precisely arranged. Each time the patient latches, the lancet body is moved further by a lancet tip. This can be displayed to the user via a counter, so that it is always apparent to the user which lancet length is currently provided for the puncture. It should be prevented that the device is clocked back so that no repeated use of a lancet tip is possible.

In FIG. 2, the lancet tips (3) are arranged at different angles from the lancet bodies (2). The lancet tips (3) can point in all directions.

Preferably, the lancet tips (3) are arranged in a plane so that the lancet (1) can be stored in a stacking magazine without damaging the lancet tips. In this star-shaped arrangement, depending on the geometry of the lancet body, up to 10 lancets can be arranged at different angles to the basic body, preferably 4 to 5 lancet tips (3). Advantageously, the

Lancet body a recess / hole (2a), which is provided as a coupling element for coupling to a correspondingly designed plunger (not shown) of a drive unit. In the example shown, the lancet is rotatably connected to the drive unit, so that due to a rotation of the plunger and thus the lancet a desired tip for a lancing process can be selected. In this way, a selection of a lancet tip is possible due to the interaction of the drive unit with the coupling element of the lancet.

In a preferred embodiment, the lancet tips (3) have a kink at their proximal end (3a) which adjoins the lancet body (2). By this kink, the lancet tip (3) from the plane of the body and the remaining lancet tips are herausgeknickt, whereby a selection of the desired lancet tip (3) can take place. During the lancing process, the lancing process (1) is used to puncture the entire lancet.

FIG. 3 shows a section of a lancet (1), wherein the lancet tip (3) shown here, which is located on the lancet body (2), has a region with several fold lines (4a, b, c). The crease line (4a) extends from the distal end 3b of the lancet tip (3) in the direction of the proximal end (3a) of the lancet tip (3). This bending line (4a) may extend over the entire tip region of the lancet tip (3) or only over a partial region of the lancet tip (3).

Further crease lines (4b and 4c) may extend laterally from the first crease line in the direction of the proximal end (3a) of the lancet tip (3).

FIG. 4 shows a lancet tip (3) with an integrated microsampler (5). The lancet tip (3) with integrated microsampler (5) can be bent over a bend line (4a) at the proximal end (3a) of the lancet tip (3).

FIG. 5 shows a particular embodiment of the lancet tip (3) with integrated microsampler (5), wherein, as in FIG. 3, there are a plurality of crease lines (4a 4b and 4c).

FIG. 6 shows a system with a carrier tape (10) which is wound on two different rolls (IIa and Ib), wherein one of the rolls (IIa) can contain unused lancets (1) or test elements (13), while IIb) used lancets (1) or test elements magazined. The system may further comprise a buckling element (12) which, after selection of the corresponding lancet tip (3), the lancet kinks. In this case, the buckling element (12) serves as a means for selection (16). Further, the system may include an optic (14) and means for driving the lancet, such as a plunger (15). Also, the optic (14) can serve as a means for selection (16), if this is designed as a sensor for a marking on the carrier tape (10) or the lancet body (2) with lancet tips (3)

FIG. 7 a shows a circular arrangement of lancet tips (3) and lancet carriers (23) in the form of a lancet wheel (24). Here, the lancet tips (3) to the lancet carriers (23) can be bent and thereby also have different lengths. The lancet carrier (23) can be separated by furrows, so that everyone

Lancet arm (25) from the plane of the circular lancet (1) can be deflected. This can be used to execute the lancing process. At the same time, the lancet arm (25) makes a circular movement during the puncture. The lancet arm (25) can have webs (26) which limit the penetration depth, since they prevent further penetration of the lancet when it is pierced into the body. By a corresponding pre-bending of the lancet arms (25), the lancet moves back into the original position after the puncture by itself, as shown in Figure 9 The lancet arm (25) can be deflected both upwards and downwards due to the flexibility become. Since the lancet arm (25) makes a circular movement during the piercing movement, the user's body is not pierced vertically but in a circular motion. This has the consequence that not only force is applied perpendicular to the skin but also lateral forces act. As a result, the pain during puncture is greater than with a conventional lancet, which is inserted vertically into the skin. In order to reduce these lateral forces during the lancing process, the lancet tip (3) of the lancet (1) can have a cutting edge (70) which cuts through the skin of the body and does not puncture the skin, as in conventional lancets.

FIG. 7b shows a lancet (1) which has a cutting edge (70) at its distal end (3b). The cutting edge (70), unlike a lancet tip (3) (as shown in the previous figures), does not have edges which run uniformly towards each other and unite in the tip (3). At the cutting edge (70), the edges (71) and (72) of the cutting edge (70) converge towards the tip (73) at different angles. Depending on the arrangement of the cutting edge (70) to the lancet body (25), the first side edge (71) and the second side edge (72) extend in the plane of the circular path or transversely thereto. Are the side edges (71) and (72) arranged in the plane of the circular path, do the ground side edges (71) and (72) can cut in the direction of movement, while the transverse to the circular path arranged side edges (71) and (72) also cross transverse to the direction of movement, which can lead to more pain during the puncture. A similar ausgestaltetes wheel, such as the lancet wheel (24) can also be designed for test elements, which together with the lancet wheel (24) in one

System can be arranged so that puncture and blood transfer can be performed at an opening.

In FIGS. 8 a-d, a device is shown schematically, which ensures the kinking before the puncture and the bending back after the puncture. This device is preferably to be used with lancets mounted on a carrier tape (10). But it can also be used for lancets that are not mounted on a carrier tape (10). Before the puncture procedure, the lancet (1) is to be bent out of the carrier band plane. This condition is shown in FIG. 8a. For this purpose, the carrier tape (10) between the lower part (82) and the upper part (81) of the holding element (80) and the slider (89) is clamped.

As a result, a part of the carrier tape (10) is folded over and thereby slipping during the buckling process is prevented. Subsequently, the lancet (1) is bent at a predefined location with the aid of a transfer element (84), which is driven by a plunger (85). The Umlegeelement (84) exerts in this process so much pressure on the lancet, that at the point where it touches the upper part (81) of the holding element (80), as shown in Figure 8b. As shown in Figure 8c, after the buckling process, the holder of the carrier tape (10) by the holding element (80) is released and the holding member (80) can be rotated out of the carrier band level, so as not to hinder the lancing process. The lancet (1) can be moved by moving the slider to the puncture. In order to be able to influence the puncture depth during the lancing process, the holding element (80) is connected to a carriage (88) which is able to displace the holding element (80), which serves as a reference element for adjusting the puncturing depth. By moving the holding element (80), the upper part (81) of the holding element (80) pushes more or less far over the carrier tape (10) towards the lancet tip. As a result of this displacement, the lancet tip is of different lengths after the bending process, depending on how far the retaining element (80) is moved forwards or backwards. The displacement of the carriage (88) can preferably be done by a sliding thread (87). In addition, on the holding element (80) a Be bent back element (86) be mounted so that after the puncture of the lancet (1) in the body, the lancet (1) bends back into the carrier band plane.

FIG. 9 shows a lancet arm (25) which has a curvature (93) which protrudes slightly out of the plane of the lancet arm (25). This vault may contain the channel of the microsampler. In this way, a test element can be brought easily to the curvature in order to transmit the blood that has been collected in the channel of the microsampler.

LIST OF REFERENCE NUMBERS

1 lancet 85 pestle

2 lancet body 86 return element

3 lancet tip 87 sliding thread

3 a proximal end 88 carriages

3 b distal end 89 pusher

4 a 1. Crease line 90 Camber

4 b 2. Crease line

4 c 3rd bend line

5 microsamplers

10 carrier tape

I i a 1. RoUe

I Ib 2. RoUe

12 buckling element

13 test elements

14 optics

15 pestles

16 means for selection

23 lancet carriers

24 lancet wheel

25 lancet arm

26 footbridge

70 cutting edge

71 first cutting edge

72 second cutting edge

80 holding element

81 upper part retaining element

82 lower part retaining element

83 Sterile protection

84 transfer element

Claims

claims

A device for obtaining body fluid, comprising: at least one lancet, comprising a lancet body having at least two tips, which have different lengths, characterized in that the device has a means for selection, with the aid of a tip is selected, so that a A piercing operation with a defined penetration depth into a body part applied against the device, depending on the length of the selected tip, wherein at least one of the non-selected tips is positioned in the device during a piercing operation such that no piercing action is performed with the non-selected tip.

2. Apparatus according to claim 1, characterized in that the at least two tips are arranged in different directions on the lancet body.

3. Apparatus according to claim 1 or 2, characterized in that the at least two peaks are arranged in a star shape on the lancet body.

4. The device according to claim 1, characterized in that the at least two peaks are arranged linearly on the lancet body.

5. Apparatus according to claim 1 to 4, characterized in that the device has a drive unit for moving the lancet.

6. Device according to one of claims 1 to 5, characterized in that the

Device has a buckling device, which causes the change in the orientation of the tips relative to the lancet body.

7. Device according to one of claims 1 to 6, characterized in that at least one tip is changeable in its orientation relative to the lancet body.

8. Device according to one of claims 1 to 7, characterized in that the at least one lancet is a flat lancet.

9. Device according to one of claims 1 to 8, characterized in that the at least two peaks have a kink area, which has at least one structure with a changed rigidity.

10. Device according to one of claims 1 to 9, characterized in that extending at least one structure with changed rigidity over a part of the longitudinal extent of the tip region.

11. Device according to one of claims 9 or 10, characterized in that upon application of a threshold force on the lancet, the at least one structure with modified stiffness, kinking of the adjacent surfaces causes.

12. Device according to one of claims 1 to 11, characterized in that the lancet is arranged on a carrier tape.

13. The device according to claim 12, characterized in that the at least one lancet is arranged in different orientations on the carrier tape.

14. The apparatus of claim 12 or 13, characterized in that on the carrier tape further at least one test element is arranged.

15. Device according to one of claims 12 to 14, characterized in that the lancet is fixed at its proximal end on the carrier tape.

16. Device according to one of the preceding claims, characterized in that at least the lancet tips have a sterile protection.

17. Device according to one of the preceding claims, characterized in that the device has a means for buckling back of the bent tips.

18. Device according to one of the preceding claims, characterized in that the device has a test element

19. Device according to one of the preceding claims, characterized in that the device has a detection unit.

20. A lancet for piercing a body part, comprising: a lancet body having at least two tips, which have different lengths, characterized in that the lancet is configured such that a tip of the at least two tips is selectable, so that a lancing process with defined

Penetration depth depending on the length of the selected tip, wherein at least one of the unselected tips may be positioned during a piercing operation relative to the selected tip such that no piercing operation is performed with the non-selected tip.

21. A lancet according to claim 20, characterized in that a tip is selectable by a kink area in the lancet.

22. Lancet according to claim 20 or 21, characterized in that the lancet has a coupling element, by which the lancet to a drive unit of a

Blood collection system can be coupled.

23. Lancet according to claim 22, characterized in that the coupling element allows a coupling of the lancet in different positions relative to the drive unit.

24. Lancet according to claim 22, characterized in that the lancet has a plurality of coupling elements.

25. Lancet according to claim 22, characterized in that the lancet tips on the lancet body have different orientations.

26. Device according to one of claims 1 - 19 with a lancet comprising a lancet body with at least two tips, which have different lengths, wherein the lancet is configured such that a tip of the at least two tips is selectable such that a piercing action of defined piercing depth can be made depending on the length of the selected tip, wherein at least one of the unselected tips is such during a piercing relative to that selected tip can be positioned so that with the non-selected tip no lancing is performed.